{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2018-10810", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190104", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20181212", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "9900", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190104", "brand_name": "DA VINCI XI SURGICAL SYSTEM", "generic_name": "DA VINCI XI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS4001-01", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/17/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250807", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20190104", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "70 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Injury", "Blood Loss", "Death", "Injury", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20200317", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8216271", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20181213", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "132035573", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT¿S OPERATIVE COMPLICATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2018. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, A PULMONARY ARTERY WAS ALLEGEDLY ¿HIT¿ AND AS A RESULT, THE PATIENT BLED OUT AND EXPIRED. ALTHOUGH IT WAS REPORTED THAT THE EVENT WAS POSSIBLY RELATED TO A SURGICAL TECHNIQUE ISSUE AND AN UNEXPECTED VESSEL, THE ROOT CAUSE OF THE VESSEL INJURY IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM OCCURRED." }, { "mdr_text_key": "132035574", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING COMPLETION OF A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, A PULMONARY ARTERY WAS ¿HIT¿ AND AS A RESULT, THE PATIENT BLED OUT AND EXPIRED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(6) 2018 AND (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE CSR DID NOT KNOW WHAT SURGICAL TASK THE SURGEON WAS PERFORMING WHEN THE VESSEL WAS ALLEGEDLY ¿HIT.¿ ACCORDING TO THE CSR, THE GENERAL CONSENSUS SO FAR WAS THAT THE EVENT WAS RELATED TO ¿GENERAL SURGICAL TECHNIQUE AND AN UNEXPECTED VESSEL.¿ THE CSR SPOKE TO THE HEAD OF THE DEPARTMENT. ACCORDING TO THE CSR, THE HEAD OF THE DEPARTMENT BELIEVES THE VESSEL TORE DUE TO TENSION AND TRAUMA DURING DISSECTION BUT IT IS IMPOSSIBLE TO KNOW FOR CERTAIN WITHOUT VIDEO. THE SURGEON HIMSELF REITERATED THAT HE WAS NOT WORKING ON THE VESSEL AT THE TIME AND IT WAS THE RESULT OF TENSION ON A SMALL WEAK BRANCH. HOWEVER, THE ROOT CAUSE OF THE VESSEL INJURY CANNOT BE CONFIRMED." }, { "mdr_text_key": "282090136", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 03/17/2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE PATIENT'S AGE AND GENDER - (B)(6) MALE. OTHER PATIENT INFORMATION WAS REQUESTED, BUT WAS NOT OBTAINED. IT WAS NOTED THAT THE PATIENT DIED DUE TO BLOOD LOSS FROM THE PULMONARY ARTERY INJURY, HOWEVER THERE WAS NO AUTOPSY OR DEATH CERTIFICATE PROVIDED TO ISI. THIS SUPPLEMENTAL REPORT, WITH ADDITIONAL INFORMATION COLLECTED, IS IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED MARCH 6, 2020." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/11/2020" } ] }